Newport E360S-WW-INRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521541122), received between Apr 10, 2017 and Aug 9, 2017 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 9, 2017No Display/Image; Device Displays Incorrect Message; No Display/Image; Device Displays Incorrect Message

  IT WAS REPORTED THAT E360 VENTILATOR HAD A BLANK DISPLAY. ALTHOUGH REQUESTED, INFORMATION PERTAINING TO THE USE OF THE DEVICE AT THE TIME OF THE REPORTED EVENT AND PATIENT OUTCOME (IF APPLICABLE) HAS NOT BEEN PROVIDED. MEDTRONIC WAS NOT AUTHORIZED TO EVALUATE/REPAIR THE DEVICE AS THE PRODUCT IS NOT IN MEDTRONIC CONTROL. THE REPAIR WAS COMPLETED AT A NON-MEDTRONIC LOCATION AND THE SERVICE PROVIDER (SP) FOUND THE SINGLE BOARD COMPUTER AND AN O2 SENSOR ERROR NEED TO BE REPLACED. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED WITHOUT THE PRODUCT RETURN. SHOULD NEW INFORMATION BECOME AVAILABLE OR IF THE PRODUCT IS RETURNED TO THE MANUFACTURER FOR INVESTIGATION THE COMPLAINT WILL BE RE-EVALUATED.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 6778103 ↗
• MalfunctionAug 8, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE E360 VENTILATOR HAD A LEAKAGE. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME OF THE EVENT. MEDTRONIC WAS NOT AUTHORIZED TO EVALUATE/REPAIR THE DEVICE AS THE PRODUCT IS NOT IN MEDTRONIC CONTROL. THE REPAIR WAS COMPLETED AT A NON-MEDTRONIC LOCATION AND THE SERVICE PROVIDER (SP) FOUND A LEAKAGE IN AIR TUBING. THE SP RECONNECTED ALL TUBING TO ADDRESS THE ISSUE. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED WITHOUT THE PRODUCT RETURN. SHOULD NEW INFORMATION BECOME AVAILABLE OR IF THE PRODUCT IS RETURNED TO THE MANUFACTURER FOR INVESTIGATION THE COMPLAINT WILL BE RE-EVALUATED.

  Patient problems: No Patient Involvement

  MAUDE report 6774343 ↗
• MalfunctionJul 31, 2017Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE E360 VENTILATOR FAILED CALIBRATION FOR FLOW SENSOR. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME OF THE EVENT. MEDTRONIC WAS NOT AUTHORIZED TO EVALUATE/REPAIR THE DEVICE AS THE PRODUCT IS NOT IN MEDTRONIC CONTROL. THE REPAIR WILL BE COMPLETED AT A NON-MEDTRONIC LOCATION. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED WITHOUT THE PRODUCT RETURN. SHOULD NEW INFORMATION BECOME AVAILABLE OR IF THE PRODUCT IS RETURNED TO THE MANUFACTURER FOR INVESTIGATION THE COMPLAINT WILL BE RE-EVALUATED.

  Patient problems: No Patient Involvement

  MAUDE report 6754150 ↗
• MalfunctionJun 16, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE E360 VENTILATOR GENERATED A OXYGEN SUPPLY LOSS ALARM. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME OF THE REPORTED CONDITION. COVIDIEN/MEDTRONIC WAS NOT AUTHORIZED TO EVALUATE/SERVICE THE DEVICE SO THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. A NON-COVIDIEN /MEDTRONIC SERVICE PROVIDER CHECKED THE VENTILATOR AND FOUND REPORTED PROBLEM. THE SERVICE PROVIDER CROSSCHECKED SERVO VALVE WITH WORKING VENTILATOR AND CONFIRMED IT WAS DETERMINED THAT THE SERVO VALVE NEEDS TO BE REPLACED.

  Patient problems: No Patient Involvement

  MAUDE report 6648935 ↗
• MalfunctionJun 7, 2017Leak/Splash; Leak/Splash

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT

  Patient problems: No Information; No Patient Involvement

  MAUDE report 6618635 ↗
• MalfunctionMay 3, 2017Device Inoperable; Device Inoperable

  IT WAS REPORTED THAT THE E360 VENTILATOR HAD INCOMPATIBLE DISPLAY BOARD SOFTWARE AND DOES NOT ACCEPT ANY COMMAND. PATIENT INVOLVEMENT INFORMATION WAS NOT PROVIDED BY THE CUSTOMER. MEDTRONIC WAS NOT AUTHORIZED TO EVALUATE/SERVICE THE DEVICE SO THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. THE VENTILATOR WAS EVALUATED AND IT WAS REPORTED THAT THE SINGLE BOARD COMPUTER AND ITS CONNECTIONS WERE CLEANED. THE VENTILATOR IS IN WORKING CONDITION.

  Patient problems: No Information

  MAUDE report 6541252 ↗
• MalfunctionApr 10, 2017Failure to Calibrate; Failure to Calibrate

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION OF THE OXYGEN SENSOR. THE VENTILATOR WAS NOT ON A PATIENT AT THE TIME OF THE EVENT. REPAIR WILL BE COMPLETED AT A NON-MEDTRONIC LOCATION AND THE PRODUCT IS NOT IN MEDTRONIC CONTROL. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED WITHOUT THE PRODUCT RETURN. THE COMPLAINT WILL BE CLOSED AND REOPENED/UPDATED SHOULD NEW INFORMATION BECOME AVAILABLE OR IF THE PRODUCT IS RETURNED TO THE MANUFACTURER FOR INVESTIGATION. THE INFORMATION HAS BEEN ADDED TO THE DATABASE FOR TRENDING PURPOSES AND TRENDS WILL CONTINUE TO BE MONITORED. A CAPA IS NOT REQUIRED AT THIS TIME.

  Patient problems: No Patient Involvement

  MAUDE report 6475592 ↗